Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

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The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.

Description

An ODI is defined as a time period of less than 3 months during which ...

Description

An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.

Time Frame

baseline, 14 months (3-4 cycles), 17 months

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Intent to treat population

Arm/Group Title

Proellex 25 mg

Proellex 12.5 mg

Placebo Comparator

Arm/Group Description:

Proellex® 12.5 mg twice daily

Proellex® 12.5 mg once daily

Placebo capsule once daily

Arm/Group Description:

Proellex® 12.5 mg twice daily

Proellex® 12.5 mg once daily

Placebo capsule once daily

Overall Number of Participants Analyzed

22

22

21

Mean (Standard Deviation)

Unit of Measure: mL

Baseline

136.29
(88.12)

179.95
(119.83)

130.86
(147.10)

Change from baseline to end of ODI 1

-41.00
(71.63)

-63.57
(100.83)

NA [1]
(0000)

Change from baseline to end of ODI 2

-38.60
(213.63)

-33.33
(240.42)

-9.90
(125.88)

Change from baseline to end of ODI 3

-7.00
(69.63)

-222.50
(121.62)

-31.29
(175.46)

Change from baseline to end of ODI 4

NA [2]
(0000)

-48.00
(11.31)

NA [2]
(0000)

Change from baseline to 17 months

1.43
(94.09)

-211.40
(148.06)

17.50
(192.88)

[1]

No data change for subjects randomized to placebo group at the end of ODI 1

[2]

Statistical analysis not completed due to low number of subjects having ODI 4